Skip to main content

Applications

Gene Therapy - Viral Vector

Virotherapy/Oncolytic Virus:

Clients have long appreciated Viracor’s expertise in anti-viral and vaccine development.  In fact, our combined experience with viral vectors and de novo assay development was instrumental to our role in the development of the first FDA-approved oncolytic virus immunotherapy for the treatment of cancer (melanoma) in 2015.

We offer a broad portfolio of clinically relevant testing services to aid in viral vector-based gene therapy development:

  • Cell-based assays for immune function and proliferation
  • Transgene or target protein expression
  • Detection and quantification of the viral genome in serum (or target tissue)
  • qPCR and ddPCR for replication-competent lentivirus (RCL) and replication-competent retrovirus (RCR) testing, and measuring gene persistence
  • Quantitative analysis of biodistribution/viral shedding by qPCR for both primary and secondary outcomes measures, as well as safety testing to assess potential for transmission
  • Assays for measuring anti-drug antibodies (ADA) against the oncolytic virus
  • Neutralizing Antibody (NAb) assays to detect neutralizing activity against the vector

Chronic Viral Infection Testing for Immunotherapy Trials:

  • Human Immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Human T-lymphotropic virus (HTLV)
  • Cytomegalovirus (CMV)
  • Epstein-Barr virus (EBV)
  • Adenovirus (ADV)
  • Human herpesvirus (HHV-6, HHV-7, HHV-8)
  • BK virus (BKV)
  • John Cunningham (JC) virus
Back to top